Emerging Clinical Trial Locations - Eastern Europe: Market dynamics and the changing healthcare and regulatory environment

리서치사	Business Insights
발행일	2009년 06월	상품코드	92686
페이지 정보	147 pages
가격	US $ 3,835 ￦ 4,569,400 PDF by E-mail (Single User License) US $ 14,381 ￦ 17,134,900 PDF by E-mail (Global Site License)

한글목차
영문목차
관련자료

영문목차

Abstract

Over the last decade pharmaceutical and biotechnology companies have entered a period where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. It has now become generally acknowledged that the current business models have become both economically unsustainable and operationally unsuited to act quickly enough to produce the types of innovative treatments that will be demanded by global markets. Major issues confronting both the pharmaceutical and biotechnology market are: the requirement to reduce the escalating costs and risks associated with drug development; and reduce clinical trial timelines by improving patient recruitment and improving the efficiency of clinical trial results analysis and reporting. The biopharmaceutical industry has recognized the opportunities and advantages that exist by conducting clinical trials in what are referred to as the emerging markets. This report identifies market dynamics and key regulatory changes, and analyzes the implications and factors which need to be taken into consideration when conducting clinical trials in Eastern Europe.

Executive summary

Introduction
Conducting clinical trials in emerging markets
Central and Eastern Europe

Chapter 1 Introduction

Summary
Introduction
Generic competition
Intellectual property protection
Managing regulatory compliance
Cost containment and government funding restrictions
Obtaining and maintaining competitive advantage
Recruitment and retention of a skilled workforce
Improvement to R&D productivity
High risks and costs associated with drug development
- Escalating costs of clinical trials
- Global increase in the number of clinical trials conducted
- Longer R&D timelines
- Increased attrition rates during R&D
Clinical trial study design and planning
Clinical trial study design
Clinical trial study protocol
Clinical trial sponsors
Identifying and recruiting patients
Role of CROs
Information technology and new technology platforms
Drivers of development
- Advantages associated with EDC
- Advantages of electronic Clinical Trial Management Systems
- (CTMS)
- Cost saving
Issues and challenges
Electronic records and signatures
Integration and linkage of electronic systems
Security and confidentiality of patient data

Chapter 2 Conducting clinical trials in emerging markets

Summary
Introduction
Market drivers
Rapid recruitment of patients and clinical trial investigators
Significant cost benefits
Improving transparency and efficiency of regulatory systems
Harmonization and standardization of regulatory requirements
Expansion of CROs
Conducive hospital infrastructure and healthcare systems
Enhanced clinical site effectiveness
Future commercial value
Key barriers
Concerns over the clinical trial transparency
- Publication bias
- Selective reporting
- Duplicate publication
- Conflict of interest
Availability of demographic and epidemiology data
Critical components concerning capacity building
Assimilation of individual national regulations and guidelines
- United States
- Japan
- European Union
Language translation
Ethical challenges
- Health needs of the population under study
- Respect for potential and enrolled subjects
- Ethical oversight
- Lack of review by institutional review board (IRB)
- Absence of informed consent
- Scientific validity
Inadequate protection of intellectual property
Clinical trial logistics
- Import licenses and applications
- Customs regulations
- Storage, handling and distribution
Selecting an appropriate CRO
Patient enrolment
- Site selection
- Site activation
- Patient recruitment

Chapter 3 Central and Eastern Europe

Summary
Introduction
Geographic
- Czech Republic
- Poland
- Russian Federation
Political
- Czech Republic
- Poland
- Russian Federation
Economic
- Czech Republic
- Poland
- Russian Federation
Market dynamics
Vital statistics
- Population statistics
- Epidemiology and prevalence of major diseases
Pharmaceutical market
CRO market
- Czech Republic
- Poland
- Russian Federation
Clinical trial market
- Czech Republic
- Poland
- Russian Federation

Market drivers
Large eligible treatment naive population who exhibit high retention rates
Large pool of dedicated, well trained and motivated investigators
Cost savings
Centralized healthcare systems and well-developed referral systems
Entry of Russian Federation into the World Trade Organization (WTO)
Positive assessments by the US FDA (Poland)

Key barriers
Poor hospital infrastructure with inadequate medical equipment
Cultural differences and issues
Potential delays importing the study drug (Russia)
Concerns and issues obtained from regulatory inspections by the FDA
(Russia)
Lack of clinical trial experience amongst hospital staff and hospital services
Healthcare
Healthcare system - Czech Republic
Hospital resources - Czech Republic
Healthcare system - Poland
- Ministry of Health
- National health fund
- Territorial self-government administrations
Hospital resources - Poland
Healthcare system - Russian Federation
Hospital resources - Russian Federation
Regulation and legislation
Regulatory authorities
- SUKL - Czech Republic
- NIL - Poland
- RZN - Russian Federation
Clinical trial regulation
- Czech Republic
- Poland
- Russian Federation
Legislation
- Poland removes tax block for clinical trials
- Decree no. 226/2008 on good clinical practices - Czech Republic
- Russia
Outlook

Chapter 4 Appendix

Introduction to clinical trials
Clinical trial phases
- Phase I
- Phase II
- Phase III
- Phase IV
What is a clinical trial
Clinical trials of pharmaceutical agents
Types of clinical trial
- Pilot studies
- Proof of concept (PoC) trials
- Randomized clinical studies
- Controlled clinical trials
- Parallel studies
- Parallel group trials
- Cohort studies
- Case control studies
Role of the chief investigator
Clinical trial protocol and procedure
Determination of the clinical trial size
Role of the coordinating centre and trials unit
Role of the trial coordinator
The trial principle investigator
Forms and data management
Trial data analysis and evaluation
Ethical issues and conduct of clinical trial research
Interpretation and publication of clinical trial results
Principle regulatory agencies
The European Agency for the Evaluation of Medicinal Products (EMEA)
The United States Food and Drug Administration (US FDA)
Japanese Ministry of Health, Labor and Welfare (MHLW)
Methodology statement
Primary Data and Information Gathering
Secondary data and information gathering
Definitions of Product-Life Cycle stages
Glossary of abbreviations and acronyms

List of Figures

Figure 1.1: Key issues facing Pharma and Biotech companies
Figure 1.2: Cost of bringing a drug to market ($m), 1975-2008
Figure 1.3: Pharmaceutical R&D expenditure ($bn), 2004-2009e
Figure 1.4: Biotechnology R&D expenditure ($bn), 2004-2009e
Figure 1.5: Cost of clinical trials in the US ($bn), 2005-2011e
Figure 2.6: Comparison of locations across selected countries
Figure 2.7: Korean Food and Drug Administration (KFDA) Approval Process
Figure 2.8: CRO Segment Leaders
Figure 2.9: Enhanced clinical site effectiveness (patients per site) in the emerging countries
Figure 2.10: Fewer ineffective sites in the emerging countries
Figure 2.11: Critical components for capacity building/conducting clinical trials
Figure 2.12: Assessing clinical trial location feasibility
Figure 2.13: CRO selection criteria
Figure 3.14: Pharmaceutical market by selected Central and Eastern European countries, 2007
Figure 3.15: Clinical trials Europe
Figure 3.16: Clinical trials by phase (no trials) in the Czech Republic, 2008
Figure 3.17: Clinical trials market ($m) in Poland, 2007-2010
Figure 3.18: Clinical trials by therapy area (%) in Russia, 2008
Figure 3.19: Clinical trials by phase (%) in Russia, 2008
Figure 3.20: FDA inspection deficiencies in Russian sites

List of Tables

Table 2.1: Demographics of selected emerging markets, 2007
Table 2.2: Ethical principles & their application for research
Table 3.3: Central and Eastern Europe population projection (m people), 2009
Table 3.4: Population statistics - Russia
Table 3.5: Principle city population statistics - Russia, 2008
Table 3.6: Estimated total deaths (thousands) by cause and by selected country
Table 3.7: Top 10 pharmaceutical companies ($m) in Russia, Poland and the Czech Republic, 2008
Table 3.8: Major CROs operating in Eastern Europe (including Poland and Czech Republic), 2009
Table 3.9: Top 10 Russian regions by no. of new investigative sites, 2006-2008
Table 3.10: Snapshot of hospitals in the Czech Republic
Table 3.11: Snapshot of hospitals in Poland
Table 3.12: Contact details regulatory authorities in selected Central and Eastern European countries
Table 3.13: Fees for clinical trial application (€ ) in the Czech Republic, April 2009
Table 3.14: Guidelines and Forms for Clinical Trials Czech Republic
Table 3.15: Checklist of documents for initial application in Czech Republic